N/A Completed N=20 Randomized Single-blind Prevention

EPO2-PV: Evaluation of Pre-Oxygenation Conditions in Morbidly Obese Volunteer: Effect of Position and Ventilation Mode

Morbid Obesity · Bariatric Surgery Candidate

Source: ClinicalTrials.gov NCT02121808 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2018

Primary outcomePrimary: Functional Residual Capacity — 2573; 2145; 2456; 2219 ml

Summary

The risk of complications associated with airway management in obese patients is significant. The results of pre-oxygenation allow a prolonged non-hypoxic apnea time for the clinician. The increase in FRC and non-hypoxic apnea time is correlated. The best condition to accomplish the pre-oxygenation in morbidly obese patient is still undetermined in medical literature. This study is designed to evaluate the effect of different positions combined with different ventilation modes during the pre-oxygenation phase of anesthesia's induction. EPO2: PV will evaluate the effect of different combinations of positions and ventilation modes on pulmonary volumes (mainly functional residual capacity) in a morbidly obese volunteer.

Outcome Measures

Outcome	Result	p-value
PRIMARY Functional Residual Capacity	2573; 2145; 2456; 2219; 2684; 2282	—
SECONDARY Diaphragmatic Amplitude.	—	—
SECONDARY Respiratory Mechanics	—	—
SECONDARY Patient's Comfort	—	—

Eligibility Criteria

Inclusion Criteria

BMI 40 - 80 kg / m2
Waist circumference: Men: More than 130 cm
Waist circumference: Women: More than 115 cm

Exclusion Criteria

Facial hair
Cranio-facial abnormality
Claustrophobia
Asthma
COPD (defined by FEV1 < 80 %)
Severe cardiovascular disease (defined by NYHA ≥3)
Pregnancy
Tobacco use
NI-CPPV Intolerance documented by a respiratory specialist (pneumologist).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02121808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.